Regulatory Affairs and Pharmacovigilance

We offer regulatory support with registration procedures and maintenance of approvals for medicinal products, food supplements, medical devices, food for special medical purposes, infant and follow-on formulas. We are centralized in Medis’ Headquarters in Slovenia and have local regulatory specialists in Austria, Bosnia and Herzegovina, Croatia, Hungary, Kosovo, Macedonia, Montenegro and Serbia.

Medis' Regulatory Affairs department works very closely with other departments in Medis, especially with Sales and Marketing team. This is crucial for optimal maintenance of the medicines through their life cycles and to ensure constant supply of the medicines to the market. We offer "all-in-one-service" for various types of products.

Medicinal products:

Regulatory consulting regarding local requirements and strategy advice with the support in our territory

Preparation and maintenance of documentation according to local legislation for NP, MRP and DCP (registration, renewal, variations, notification, MAH transfer...), submission and follow up the status of procedures

Publishing of eCTD format or NeeS format

High quality translation activities of Patient Information

QRD formatting

Preparation/check of local labelling, foreign pack applications

Medical devices:

Regulatory consulting regarding local requirements and strategy advice with the support in our territory

Preparation and maintenance of documentation according to local legislation (entry into local registers, renewal, variations, notification, MAH transfer...), submission and follow up the status of procedures

High quality translation activities of packaging material

Preparation/check of local labelling, foreign pack applications

Food supplements, food for special purposes:

Regulatory consulting regarding local requirements and strategy advice with the support in our territory (identifying the possibility of marketing a product in the dietary supplement category)

Preparing packaging labels in accordance with the legislation requirements

Majority of Medis' regulatory specialists have been with the company for more than a decade. Vast experience and know-how enables us great insight into development of legislation and thus significantly fastens regulatory procedures.

Pharmacovigilance

Medis' Drug Safety Office provides support in safety surveillance of your products and assures the safety of medicines to the patients.

We provide efficient pharmacovigilance system for safety monitoring of medicinal products in the markets of Austria, Bosnia and Herzegovina, Croatia, Hungary, Kosovo, Macedonia, Montenegro, Serbia and Slovenia.

Medis, d.o.o., adequately operates and maintains a management system which meets the requirements of the standard ISO 9001:2008 for marketing, sales and distribution of pharmaceutical and medical products as well as standard ISO 9001:2008, including HACCP as required by CAC/RCP 1-1969/2003 for marketing of dietary supplements and foods for special requirements. Medis, d.o.o., is also a proud member of Slovene-German Chamber of Commerce and Industry, American Chamber of Commerce and Slovenian Chamber of Commerce.